Quality Engineer
4 weeks ago
Quality Engineer – Onsite in Wallingford, CT
A respected plastic manufacturer in Wallingford, CT is looking for a Quality Engineer to join their team. The Quality Engineer is responsible for all Quality Assurance / Quality Control processes, including internal auditing, quality improvement activities, regulatory compliance, as well as interaction with customers and suppliers. The Quality Engineer maintains and continuously improve the Quality Management System to comply with the most current quality system standards.
Responsibilities:
Receive/track/investigate and respond to customer complaints including issuing RMA’s
Review and lead solutions for Non-Conformance management
Setting up and maintaining control and documentation procedures.
Responsible for monthly reporting of KPIs.
Leads corrective and preventative action (CAPA’s) management
Oversight of Calibration program including maintaining GageTrak
Risk management plan and life cycle maintenance required for adherence to ISO 13485 and ISO 9001.
This person will be become a Management Representative to maintain ISO 9001 & ISO 13485 certificates once 30,60,90 goal objectives are met position
Data analysis and trending to drive continuous improvement
Formulating and manage the development and implementation of goals, objectives, policies, procedures for QMS standards.
Approving and facilitating customer required validation activities
Qualifications:
Bachelor's or Associate’s degree in Engineering or related field
2+ years of experience utilizing and maintaining the Quality Management System (QMS)
Strong understanding of quality systems, ISO 9001 & ISO 13485
Excellent interpersonal and communication skills
Ability to determine and meet deadlines
Ability to work independently as well as part of a team
Analytical thinking skills
Strong problem solving, decision making, and process improvement skills
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